Benztropine Mesylate
- Product NDC
- 0615-2547
- 11-digit product format
- 006152547
- Labeler code
- 0615
- Product ID
- 0615-2547_727070e9-1e14-4aab-b015-75abd66cd910
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA089058
- Marketing category
- ANDA
- Marketing start
- 2010-02-28
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0615-2547 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0615-2547 | 0615-2547-31 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0615-2547 | 0615-2547-39 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A089058-001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | | 1988-08-10 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A089058-001 | AA |
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 6 | |